Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy
This was a multi-center, parallel, active comparator controlled, open-label, randomized (1:1)
phase III study of single agent ofatumumab compared to single agent rituximab in subjects
with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6
months after completing treatment with single agent rituximab or a rituximab-containing
regimen. Subjects must have attained a Complete Response or Partial Response to their last
prior rituximab containing therapy lasting at least six months beyond the end of rituximab
therapy. Subjects were to receive four weekly doses of single agent ofatumumab (1000 mg) or
rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2
months for four additional doses. Therefore, subjects were to receive a total of eight doses
of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of
the first four doses of therapy, after six doses of therapy, and after completion of study
therapy. Subjects were to be followed until the end of the designated follow-up period (total
study duration of 200 weeks) or until they meet the withdrawal criteria.
The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra
based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in
patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing
Regimen.
The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the
termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed
analyses results for progression free survival (PFS), overall response rate (ORR), and
overall survival (OS). Novartis accepted this recommendation and the study was closed.
Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for
futility, the primary objective was not met and some secondary endpoints, supportive of
primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics)
were removed as secondary end points.
n/a
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